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Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking

10 de março de 2017 atualizado por: Anneli Peolsson, Linkoeping University
Today there is evidence for that neck specific exercises reduce neck pain problems in patients with mechanical neck pain. However, there is a lack of consensus on how to optimize neck exercises and dosages in neck rehabilitation. More knowledge is needed to determine which and how muscles are activated in exercises thought to be neck-specific. There is neither enough knowledge of differences in neck muscle activation between patients with long standing neck problems after a whiplash trauma and healthy controls nor if the neck muscle function improved with specific neck exercises. One approach would be a real time study of deformation and deformation rate in different layers of neck muscles in patients with residual long-term neck pain and disability after a whiplash trauma. The purpose of the present study was to investigate deformation and deformation rate in different layers of dorsal and ventral neck muscles (including upper and middle part of trapezius muscle) during rest and during different exercises; arm flexion until 120 degrees, repeated arm flexion until 90 degrees, low loaded neck extension, low loaded neck muscle endurance test, shoulder elevation. Forty patients with long standing (more than 6 months but less than 3 years)patients and 40 controls matched for age and gender will be included for comparisons between patients and healthy in neck muscle activation. The investigators also include 60 patients with whiplash trauma, of those 30 patients will be randomized to A. neck specific exercises in a 3 months period and B. will 30 be on a waiting list for 3 months. Measurements are performed at baseline and at 3 months follow-up. Those patients who fulfilled the 3 months period of neck specific exercises will also be asked for a 6 months follow-up.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Antecipado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Östergötland
      • Linköping, Östergötland, Suécia, SE-58183
        • Anneli Peolsson

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 63 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • WAD II and III
  • Age 18-63 years
  • Remaining problems
  • Right handed
  • Pain on right or on both sides.

Exclusion Criteria:

  • Myelopathy
  • Earlier fracture or luxation of the cervical column, earlier neck injury
  • Spinal tumour
  • Spinal infection
  • Surgery in the cervical column
  • Malignity
  • Systemic disease or other disease or another injury contraindicated to perform the treatment program or the measurements
  • Diagnosed severe psychiatric disorder
  • Unconscious in connection to the trauma
  • Known drug abuse
  • Lack of familiarity with the Swedish language

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Neck Specific exercises
3 months of neck specific exercises for 30 patients.
Neck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises.
Outros nomes:
  • Physiotherapy with neck specific exercises
Sem intervenção: Waiting list
Thirty patients on the waiting list for 3 month before they have their intervention
Sem intervenção: Healthy controls
Forty healthy controls. Comparisons between forty included WAD patients and 40 healthy controls matched for age and gender will be investigated at baseline.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Speckle tracking analysis of muscle function
Prazo: Baseline and at 3 and 6 months follow-up. The outcome measure is going to report a change over time.
Measured with medical ultrasonography
Baseline and at 3 and 6 months follow-up. The outcome measure is going to report a change over time.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Background data
Prazo: Baseline
Background data of age, gender, social situation, work, work situation, sick-leave, income, pain history, debute of symptoms, about the accident, earlier treatment, other diseases or pain problems, expectations of treatment
Baseline
Symptom satisfaction
Prazo: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Pain intensity on visual analogue scale (VAS)
Prazo: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Symptoms in general, Neck, Arm, Headache
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Dizziness/ unsteadiness on visual analogue scale
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Pain distribution on drawing
Prazo: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Pain Disability Index
Prazo: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
Neck Disability Index
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Tampa Scale of Kinesiophobia (TSK-11 short version)
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Pain Catastrophizing Scale
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Hospital Anxiety and Depression Scale
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Euroquol
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Euroquol 5D and thermometer
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Exercise Self-Efficacy Scale
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
"How confident you are to exercise when things get in the way" Exercise self-efficacy scale is a six item scale with a five point scale (1=not at all confident and 5=completely confident).
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Self-Efficacy Scale
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
"People´s beliefs about their capabilities to produce designated levels of performance that exercise influence over events that affect their lives" Self-efficacy scale (by Altmaier) is a 20 item, 11 point scale (0=not at all confident, 10=completely confident).
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Work Ability Index
Prazo: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Physical Activity level
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Physical Outcome Measures
Prazo: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
Active range of motion of the neck, Head repositioning accuracy, hand strength, neck muscle endurance, sharpened Romberg, walking in a figure of eight, neurological examination: reflexes, sensibility and motor function
Baseline and at 3 month follow-up. The outcome is going to report a change over time.
SF-36
Prazo: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Cadeira de estudo: Anneli Peolsson, Assoc. Prof., Linkoeping University

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de fevereiro de 2011

Conclusão Primária (Real)

1 de dezembro de 2015

Conclusão do estudo (Real)

1 de dezembro de 2015

Datas de inscrição no estudo

Enviado pela primeira vez

28 de fevereiro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de março de 2012

Primeira postagem (Estimativa)

8 de março de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

13 de março de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de março de 2017

Última verificação

1 de março de 2017

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • Ultrasound on neck muscles WAD

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

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